Label: POLY SAN HAND SANITIZER- isopropyl alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 76644-0001-1, 76644-0001-2 - Packager: US Polychemical Holding Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 30, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Poly San Hand Sanitizer; Purpose
- Poly San Hand Sanitizer; Active Ingredient Section
- Poly San Hand Sanitizer; Indications & Usage Section
- Poly San Hand Sanitzer; Do Not Use Section
- Poly San Hand Sanitzer; Warnings Section
- Poly San Hand Sanitizer Gel; Stop use and ask Doctor if section
- Poly San Hand Sanitizer; Keep out of reach of children section
- Poly San Hand Sanitizer; Dosage & Administration Section
- Poly San Hand Sanitizer; Inactive Ingredient Section
- Poly San Hand Sanitizer Gel; Other Safety Information
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Poly San Hand Sanitzer Drug Facts Label
The following Hand sanitizer is manufactured according to the 1994 TFM for OTC antiseptic drug products that published in the Federal Register of June 17, 1994 (59 FR 31402).
Drug Facts
Active Ingredient: Isopropanol 75% (v/v) Purpose: Antimicrobial
Use: Hand sanitizer to help reduce bacteria on skin
Warnings: Flammable, keep away from fire or flame.
For external use only, do not use
• on children less than 2 months of age
• on an open skin wound
• in or near the eyes, ears or mouth
In case of contact, rinse eyes thoroughly with water
Stop use and ask a doctor if irritation or rash appears and lasts
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions: Put enough of the product in your palm to cover hands and rub hands together briskly until dry
Children under the age of 6 should be supervised when using this product
Other information: At or below 110°F (43°C) may discolor certain fabrics or surfaces.
Avoid freezing and excessive heat.
Store between 59-86°F (15-30°C).
Inactive ingredients: Water(Aqua),glycerol, fragrance (Parfum)
Poly San Hand Sanitizer Gallon Size 1.jpg
Poly San Hand Sanitizer Qt size 1.jpg
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INGREDIENTS AND APPEARANCE
POLY SAN HAND SANITIZER
isopropyl alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76644-0001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 2.846 L in 3.785 L Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 0.86 L in 3.785 L GLYCERIN (UNII: PDC6A3C0OX) 0.076 L in 3.785 L COUMARIN (UNII: A4VZ22K1WT) 0.000001445 L in 3.785 L HEXAMETHYLINDANOPYRAN (UNII: 14170060AT) 0.00001445 L in 3.785 L TERPINEOL (UNII: R53Q4ZWC99) 0.00001445 L in 3.785 L BENZYL ACETATE (UNII: 0ECG3V79ZJ) 0.000007225 L in 3.785 L TERPINYL ACETATE (UNII: NIT9SZT3D7) 0.000007225 L in 3.785 L PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) 0.00001445 L in 3.785 L CINNAMYL ALCOHOL (UNII: SS8YOP444F) 0.000001445 L in 3.785 L DECANAL (UNII: 31Z90Q7KQJ) 0.000001445 L in 3.785 L PHENYLACETALDEHYDE (UNII: U8J5PLW9MR) 0.000001445 L in 3.785 L ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) 0.000001445 L in 3.785 L .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) 0.00001445 L in 3.785 L GERANIOL (UNII: L837108USY) 0.00001445 L in 3.785 L BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) 0.00001445 L in 3.785 L LINALOOL, (+/-)- (UNII: D81QY6I88E) 0.00000289 L in 3.785 L 4-TERT-BUTYLCYCLOHEXANYL ACETATE, TRANS- (UNII: ATR4EHD017) 0.0000289 L in 3.785 L EUGENOL (UNII: 3T8H1794QW) 0.000001445 L in 3.785 L DIHYDROMYRCENOL (UNII: 46L1B02ND9) 0.000001445 L in 3.785 L LINALYL ACETATE, (+)- (UNII: 3ID3M89AV9) 0.000001445 L in 3.785 L LIMONENE, (+/-)- (UNII: 9MC3I34447) 0.00000578 L in 3.785 L HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q) 0.000001445 L in 3.785 L 3,3'-DIHYDROXYDIPROPYL ETHER (UNII: S1OQ81LMNA) 0.00007225 L in 3.785 L Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76644-0001-1 3.785 L in 1 BOTTLE; Type 1: Convenience Kit of Co-Package 06/12/2020 2 NDC:76644-0001-2 0.946 L in 1 BOTTLE, SPRAY; Type 1: Convenience Kit of Co-Package 06/12/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 05/08/2020 Labeler - US Polychemical Holding Corporation (078395539) Registrant - US Polychemical Holding Corporation (078395539) Establishment Name Address ID/FEI Business Operations US Polychemical Holding Corporation 078395539 manufacture(76644-0001) , label(76644-0001) , pack(76644-0001) , repack(76644-0001)